Tacrolimus ointment 01% in pityriasis alba : an open-label, randomized, placebo-controlled study

• Published in: British journal of dermatology (1951) Vol. 155; no. 1; pp. 152 - 155
• Main Authors: RIGOPOULOS, D, GREGORIOU, S, CHARISSI, C, KONTOCHRISTOPOULOS, G, KALOGEROMITROST, D, GEORGALA, S
• Format: Journal Article
• Language: English
• Published: London Blackwell 01.07.2006; Oxford; Edinburgh
• Subjects: Adolescent; Adult; Analysis of Variance; Biological and medical sciences; Child; Dermatologic Agents - therapeutic use; Dermatology; Double-Blind Method; Female; Humans; Hypopigmentation - drug therapy; Hypopigmentation - pathology; Immunosuppressive Agents - therapeutic use; Male; Medical sciences; Pityriasis - drug therapy; Pityriasis - pathology; Pruritus - drug therapy; Pruritus - pathology; Skin - pathology; Statistics, Nonparametric; Sunscreening Agents - therapeutic use; Tacrolimus - therapeutic use; Human; Allergy; Immunopathology; Skin disease; Dermatology; Lactone; Ointment; Macrolide; Atopy; randomized controlled trial; Immunomodulator; Local administration; Randomization; Treatment; Tacrolimus; Secondary effect; adverse effects; Clinical trial; Protein synthesis inhibitor; Immunosuppressive agent; Pityriasis alba
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/j.1365-2133.2006.07181.x

Pityriasis alba (PA) is a frequent reason for dermatological consultation because of its chronic course, tendency to relapse and aesthetic impact. In view of its strong association with atopic dermatitis, the objective of this open-label study was to assess the efficacy and safety of tacrolimus ointment in the treatment of PA compared with the efficacy of moisturizers. The study population consisted of 60 individuals of phototype III or IV according to Fitzpatrick's classification, aged 6-21 years. Patients were randomly assigned to one of two groups. Subjects in group A were instructed to apply tacrolimus ointment 0.1% twice daily, 12 h apart, on all hypopigmented macules. Standard moisturizers with SPF 20 sunscreen were used on all lesions applied at least 30 min apart from the tacrolimus ointment. Subjects in group B used solely the same moisturizers with sunscreen. Hypopigmented areas were evaluated at baseline and weeks 0, 3, 6 and 9 by investigators for scaling, hypopigmentation and pruritus on a scale of 0-3. Patient satisfaction was also recorded on a scale of 0-3. All adverse effects were recorded. A statistically significant improvement through time, in hypopigmentation, pruritus and scaling was observed in both groups during the course of 9 weeks. Hypopigmentation resolved from a baseline score of 2.38+/-0.64 to 1.15+/-0.54 at week 3, 0.46+/-0.51 at week 6 and 0.00+/-0.00 at week 9 for the group applying tacrolimus ointment 0.1%. The difference in improvement between the two groups was statistically significant on all three assessments for hypopigmentation (P<0.001), and for pruritus on week 6 and 9 assessments (P<0.05). Three patients (11.5%) in the tacrolimus group reported a mild transient sensation of burning. All patients in the tacrolimus group reported they were completely satisfied or just satisfied with the treatment compared with only 50% of patients using the placebo. Tacrolimus ointment 0.1% appears to be an effective and safe treatment for PA.